FDA Adverse Event
Malfunction
Summary report: N
NERIVIO INFINITY
MDR report key: 24778455
·
Received April 3, 2026
Report
- Report Number
- 24778455
- Event Type
- Malfunction
- Date Received
- April 3, 2026
- Date of Event
- March 19, 2026
- Report Date
- April 2, 2026
- Manufacturer
- THERANICA BIO-ELECTRONICS LTD
- Product Code
- QGT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
OUR OFFICE RECEIVED A PATIENT SAFETY REPORT INVOLVING A MEDICAL DEVICE, NERIVIO INFINITY, WHICH EXPLODED WHILE CHARGING. THE EVENT CAUSED DAMAGE TO THE PATIENTS CARPET BUT RESULTED IN NO INJURIES. PROVIDERS HAVE BEEN INSTRUCTED NOT TO ORDER ANY NERIVIO DEVICES. EVENT DESCRIPTION: PATIENT WAS USING A NERIVIO INFINITY DEVICE FOR HEADACHE RELIEF. THE DEVICE EXPLODED WHILE CHARGING AND CAUSED CARPET BURNS. MANUFACTURER: THERANICA BIO-ELECTRONICS. MODEL: NERIVIO INFINITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 838553 | NERIVIO INFINITY | DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE | QGT | THERANICA BIO-ELECTRONICS LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |